drugset / Trial / NCT00991159
A Study To Access The Safety And Tolerability Of RN316 (PF-04950615) When Administered To Healthy Adult Subjects
RandomizedSingle-groupDouble-blindTreatment
Summary
The study is designed to determine the safety and tolerability of RN316 when administered intravenously to healthy adult subjects. This is the first time RN316 has been given to humans.
Timeline
- Start
- 2009-11
- Primary completion
- 2010-05
- Completion
- 2010-05
Publications
- Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.
- Udata C, Garzone PD, Gumbiner B, Joh T, Liang H, Liao KH, Williams JH, Meng X. A Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for Bococizumab, a Humanized Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, and Its Application in Early Clinical Development. J Clin Pharmacol. 2017 Jul;57(7):855-864. doi: 10.1002/jcph.867. Epub 2017 Feb 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bococizumab | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Subject | Bococizumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Bococizumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Bococizumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Bococizumab | Monoclonal antibody | 12 mg/kg | Intravenous |
| Subject | Bococizumab | Monoclonal antibody | 18 mg/kg | Intravenous |
Indications
No indication recorded.